Regulatory/GMP Compliance

Jul 02, 2018
Pharmaceutical Technology
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Jul 02, 2018
Pharmaceutical Technology
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Jul 02, 2018
By Pharmaceutical Technology Editors
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
Jul 02, 2018
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
Jul 02, 2018
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Jul 02, 2018
Pharmaceutical Technology
The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.
Jun 27, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
Jun 22, 2018
By Pharmaceutical Technology Editors
FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
Jun 22, 2018
By Pharmaceutical Technology Editors
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
Jun 21, 2018
By Pharmaceutical Technology Editors
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
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